Trial of Panitumumab/Cisplatin/Fluorouracil With XRT in Esophageal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01128387
First received: May 17, 2010
Last updated: June 18, 2013
Last verified: June 2013

May 17, 2010
June 18, 2013
May 2010
December 2013   (final data collection date for primary outcome measure)
MTD of panitumumab in combination with Cisplatin/fluorouracil and radiation for locally advanced esophageal cancer [ Time Frame: approximately 18 weeks ] [ Designated as safety issue: Yes ]
From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post XRT/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information
MTD of panitumumab in combination with Cisplatin/fluorouracil and radiation for locally advanced esophageal cancer [ Time Frame: approximately 18-20 weeks ] [ Designated as safety issue: Yes ]
From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post XRT/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information
Complete list of historical versions of study NCT01128387 on ClinicalTrials.gov Archive Site
Pathologic response [ Time Frame: 20 weeks. ] [ Designated as safety issue: No ]
From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post XRT/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information
Pathologic response [ Time Frame: approximately 18-20 weeks. ] [ Designated as safety issue: No ]
From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post XRT/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information
Not Provided
Not Provided
 
Trial of Panitumumab/Cisplatin/Fluorouracil With XRT in Esophageal Cancer
A Phase I/II Study of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation Preoperatively for Patients With Locally Advanced Esophageal Cancer

The overall study objective is to evaluate the dose limiting toxicities and the recommended phase II dose of Panitumumab when combined with the standard of care treatment with cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer. The investigators will also be assessing the ability of PET imaging to predict the degree of pathologic response.

All patients will have a pre-study FDG PET scan and will receive radiation therapy and chemotherapy over a 35 day period. 4-8 weeks post radiation and chemotherapy patients will be restaged with a PET/CT scan. It is anticipated that approximately 30 patients enrolled will undergo an esophagectomy which is considered standard of care post radiation and chemotherapy. The surgery will allow us to compare this study regimen to the historical standard of care (Cisplatin/fluorouracil chemotherapy with radiation therapy).

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
Drug: Panitumumab
dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.
Experimental: Panitumumab/Cisplatin/Fluorouracil and Radiation therapy
Intervention: Drug: Panitumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Locally Advanced Esophageal cancer (stages T1N1 or T2-4 any N)
  2. Histology must be adenocarcinoma or squamous cell carcinoma
  3. Must be surgical candidate based on evaluation by a thoracic surgeon
  4. must have adequate organ function as defined by routine lab tests

Exclusion Criteria:

  1. Insitu carcinoma
  2. prior chemotherapy for esophageal cancer
  3. Metastatic (stage IV disease)
  4. Tumors <5cm from the cricopharyngeus muscle, Tumors with >75% of tumor located within the stomach
  5. Active, uncontrolled cardiac disease
  6. subjects with >Grade 2 neuropathies. -
Both
18 Years and older
No
United States
 
NCT01128387
H-2009-0214
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
Amgen
Not Provided
University of Wisconsin, Madison
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP